The first and only FDA-approved oral suspension of the potassium-sparing diuretic spironolactone

The first and only FDA-approved oral suspension of the potassium-sparing diuretic spironolactone

Now ApprovedCaroSpir® the formulation that's easy to swallow

A stable, ready to use, and consistent liquid treatment option for adult patients who have difficulty swallowing, or who cannot swallow tablets.

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Now ApprovedCaroSpir® the formulation that's easy to prescribe

CaroSpir oral suspension ensures a stable and consistent dose every time. The complexities and inconsistencies of compounding are no longer an issue.

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Now ApprovedCaroSpir® the formulation that's easy to fill

The CaroSpir oral suspension eliminates the need for additional preparation by the pharmacist or the patient.

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Now ApprovedCaroSpir® the formulation that's easy to handle

CaroSpir is an FDA-approved oral suspension of spironolactone that does not contain a black box warning.

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Now ApprovedCaroSpir® the formulation that's easy

CaroSpir is indicated for the treatment of heart failure, hypertension, and edema caused by cirrhosis. For full indication, see below.

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Introducing CaroSpir®

CaroSpir provides a stable and consistent treatment option for patients who have difficulty swallowing and are suffering from heart failure, edema caused by heart failure and cirrhosis, and hypertension. In clinical studies, other formulations of spironolactone have demonstrated significant mortality benefits and reduced the risk of hospitalization for cardiac causes.

CaroSpir does not carry a black box warning.

CaroSpir will be introduced early in the fourth quarter of 2017. Check this website for updates.

Spironolactone Oral Suspension

CaroSpir is not therapeutically equivalent to Aldactone tablets. For an equivalent dose, CaroSpir results in 15 to 37% higher serum concentration compared to Aldactone tablets. A high fat and high calorie meal (57% of the ~1000 kcal of the meal were from fat) increased the bioavailability of spironolactone (as measured by AUC) by approximately 90%. Patients should establish a routine pattern for taking CAROSPIR with regard to meals. See Prescribing Information for important dosage information.

Important Safety Information

Indications And Usage

CAROSPIR is an antagonist of aldosterone indicated for:

  • the treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure
  • use as an add-on therapy for the treatment of hypertension, to lower blood pressure in adult patients. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions
  • the management of edema in adult cirrhotic patients when edema is not responsive to fluid and sodium restrictions

Contraindications

CAROSPIR is contraindicated for patients with the following conditions:

  • Hyperkalemia
  • Addison’s disease
  • Concomitant use of eplerenone

Warnings And Precautions/Adverse Reactions

CAROSPIR may cause the following conditions.

  • Hyperkalemia
  • Hypotension and Worsening Renal Function
  • Electrolyte and Metabolic Abnormalities
  • Gynecomastia
  • Impaired neurological function/ coma in patients with hepatic impairment, cirrhosis and ascites

The most common adverse reaction (incidence > 5%) with CAROSPIR treatment is the increased occurrence of gynecomastia in men.

Talk to your healthcare provider about other possible side effects with CAROSPIR.  To report SUSPECTED ADVERSE REACTIONS, contact CMP Pharma, INC. at 1-844-321-1443 , or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.

Administration

CAROSPIR oral suspension, 25 mg/5 mL, is not therapeutically equivalent to tablet forms of spironolactone.  Follow dosing instructions for CAROSPIR.  In patients requiring a dose greater than 100 mg, use another formulation of spironolactone.  Doses of CAROSPIR suspension greater than 100 mg may result in spironolactone concentrations higher than expected.

Drug Interactions

  • Agents increasing serum potassium: Concomitant administration can lead to hyperkalemia.
  • Lithium: Increased risk of lithium toxicity.
  • NSAIDs: May reduce the diuretic, natriuretic and antihypertensive effect of CAROSPIR.
  • Digoxin: CAROSPIR can interfere with radioimmunologic assays of digoxin.
  • Cholestyramine: Hyperkalemic metabolic acidosis has been reported with concomitant use.
  • Acetylsalicylic Acid (ASA): ASA may reduce the efficacy of spironolactone.

Please see Prescribing Information for additional safety information.

Indication

CAROSPIR is an antagonist of aldosterone indicated for: the treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure; use as an add-on therapy for the treatment of hypertension, to lower blood pressure; the management of edema in adult cirrhotic patients when edema is not responsive to fluid and sodium restrictions.

Important Safety Information

CAROSPIR is contraindicated for patients with the following conditions: hyperkalemia; Addison’s disease; concomitant use of eplerenone.

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